M.U.S.T. Pedicle Screw System 03.68.921Recalls & reported problems
Medacta International SA · Pre-Contoured Ø5.5 Ti - G · Class 2 · Implant
All models of M.U.S.T. Pedicle Screw System (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630542719363), received between Aug 28, 2024 and Aug 28, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2024Migration; Migration
PRIMARY SURGERY WAS PERFORMED AT TH9-S2AI. XLIF SURGERY WAS PERFORMED AT L1-L5, TLIF SURGERY WAS PERFORMED AT L5-S. REVISION SURGERY 6 DAYS AFTER THE PRIMARY SURGERY WAS PERFORMED DUE TO THE RODS COMING OUT FROM THE MUST S2AI PEDICLE SCREW HEAD. THE PEDICLE SCREWS AT BOTH SIDES OF SA1 WERE REPLACED WITH ANOTHER COMPETITOR'S SCREW. THE ROD AT THE LEFT SIDE WAS ALSO REPLACED BECAUSE THE LENGTH OF THE ROD WAS SHORT. IN THE X-RAYS THAT WERE TAKEN DURING THE PRIMARY SURGERY, THE ROD ON THE RIGHT SIDE SEEMED TO BE SHORT, BUT BY CHANGING THE ANGLE OF FLUOROSCOPY, IT WAS CONFIRMED THAT THE ROD WAS CORRECTLY PROTRUDED ABOUT 5 MM, AND THE SURGERY WAS FINISHED. THE PATIENT AND THE CONSTRUCT IS STABLE AFTER THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 20085911 ↗
Other Thoracolumbosacral Pedicle Screw System devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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